Myth And Facts About The Evolving Role of Laparoscopic Splenectomy In Isolated High Grades Splenic Injuries In Hemodynamically Stable Patients With Blunt Abdominal Trauma. Randomized Controlled Trial.

Background: Spleen is the most common intra-abdominal organ injury in blunt abdominal trauma. Splenectomy (open or laparoscopic) is the role in treatment of severe injuries of spleen or after failure of conservative treatment. Aim of the work: Compare the outcomes between open versus laparoscopic in high grade splenic injuries. Methods: This study includes 70 patients with various grades of splenic injuries in abdominal trauma. The patients were 15 years and older. They were categorized into two groups: open splenectomy group (35 patients) and laparoscopic splenectomy group (35 patients). The study was performed from January, 2012 to July 2017. Variables included demographics data, splenic injury graded by computerized tomography, duration of operation (in minutes), intra-operative blood loss (in ml), and intraoperative blood transfusion, length of hospital stay (in days), complications and mortality. Results: There was no signicant difference or association between groups as regard age, sex and causes of splenic injury (p=0.374, 0.41, 0.38).Most cases were under 35 years old male patients exposed to motor car accidents. As regard intraoperative data, no statistically signicant difference between both groups except for blood loss and transfusion that were statistically signicant to the open group (p=0.039*).In the laparoscopic group, operational time was longer than open but no statistically signicant (p=0.11).as regard conversion, we found that 14% of laparoscopic group (5 cases) had conversion. Most cases operated by laparoscopic approach were in grade III, IV with no cases tried in grade V (p=0.06). No statistically signicant difference between both groups as regard postoperative variables except Pain (p=0.0003), and hospital stay(p=0.00) that were signicantly longer among open group.The immediate postoperative complications showed that Wound infection, Missed injuries, pancreatic stula and ileus were signicantly higher among open group (p=0.00, 0.006, 0.02, 0.0004).The delayed postoperative complications where Incisional

Results: There was no signi cant difference or association between groups as regard age, sex and causes of splenic injury (p=0.374, 0.41, 0.38).Most cases were under 35 years old male patients exposed to motor car accidents. As regard intraoperative data, no statistically signi cant difference between both groups except for blood loss and transfusion that were statistically signi cant to the open group (p=0.039*).In the laparoscopic group, operational time was longer than open but no statistically signi cant (p=0.11).as regard conversion, we found that 14% of laparoscopic group ( Conclusion: In high-grade splenic injuries patients, this study found that laparoscopic splenectomy is safe.

Introduction
Rupture spleen is the commonest incidence in trauma to the abdomen especially to the left hypochondrium. The commonest cause is road tra c accident [1][2]. Spleen may be injuries either individually or with other nearby organ injuries as kidney, bowel and ribs. Ruptured spleen is suspected in poly-traumatized patient and usually associated with decreased blood pressure and increased heart rate. [3][4][5].
Different methods are evolved aimed at grading of splenic trauma and this classi cation helped in different methods of treatment of splenic injuries. CT(Computerized Tomography) grading is important and the splenic injuries are classi ed into ve grades according to the severity of splenic injuries [6-10].
Laparoscopic total splenectomy for splenic injuries was performed in 1995 and it was performed in hemodynamically stable patients [11].Laparoscopic splenectomy in avoided in hemodynamically unstable patients or severe cases of splenic injuries with continuous severe bleeding as delay in time to intervention may endanger the patient life. [12] Laparoscopy put the open approach a side because of small operative wound and hence better cosmesis and less postoperative pain and infection. Laparoscopy also gives a panoramic view to the whole abdomen and this help not to miss associated injuries. [13].
The number of studies handling laparoscopic splenectomy in high grade injuries is not numerous.
The aim of the work, strength of the study: High grade splenic injuries necessitate urgent splenectomy and usually conducted by open approach due to rapid approach, no experienced laparoscopic splenectomy surgeons for trauma. Few studies conducted on splenic injuries treatment by laparoscopic approach but we conducted a randomized controlled clinical study on this types of injuries including high grade injuries. The role of laparoscopy is evolving in the last decades but its role in dealing with traumatic spleen is of a matter of debate. The main aim: was to compare between open and laparoscopic splenectomy in high grade splenic injuries (III-V) in hemodynamically stable patients as regard safety of the patient intraoperatively (mortality) and the second aim was to determine the role of laparoscopy in splenic trauma as having actual role (fact) or it is not supposed to be used (myth).

Patients And Methods
The design of the study: Prospective randomized clinical study conducted in our University Hospitals emergency surgery unit between Jan 2012 and July 2017 for 70 Patients admitted to high grade splenic injuries (III-V). The patients were randomly allocated into two groups: Group (A): includes 35 patients: underwent open splenectomy and Group (B): includes 35 patients: laparoscopic splenectomy. The method for calculating sample size was based on mortality rates from previous paper with study power of 80 and con dence 95 samples in each group will be 35. Patients were randomly allocated using a random sequence computer. Patients were randomly numbered in closed envelopes, which were opened just before the operation. Patients were unaware to the any group until after the study. It is the role of registration o ce.
Patient selection criteria: patients enrolled in the study are male and non-pregnant female, age 15 years and more, Preoperative sonar and CT evidence of isolated splenic injuries and Blood pressure > 90/60 mmhg, and heart rate < 120 beat. While patients excluded from the study were patients with associated other systems or abdominal injuries, successful non-operative management, or successful embolization and penetrating splenic injuries.
Types of outcome and measurement (study endpoints): Primary outcome was intraoperative mortality. Secondary outcomes are the long and short term postoperative morbidities (early and delayed complications).

Method:
Preoperative workup was done by focused assessed sonography for trauma (FAST) and CT of the abdomen. All patients of the present study subjected to immediate initial resuscitation and primary survey, followed by secondary survey and routine laboratory investigations .After resuscitation and stabilization of the vital signs, abdominal ultrasonography and computed tomography scans were carried out for all cases. (Pic 1).Preoperative consultant anesthetist's assessment. Nasogastric tube and urinary bladder catheter. With induction of anesthesia, metronidazole 500 mg and ceftriaxone 1gm. given intravenously. General anesthesia with cuffed endotracheal intubation. All surgeries were done in monocenter in trauma surgery unit for duration of 5years by 3 surgeons quali ed in laparoscopic splenectomy surgery following the principles of laparoscopic surgery. Each surgeon had an experience of previous 100 laparoscopic splenectomies for elective cases. At least one of three senior surgeons was always present to ensure inclusion criteria.
A laparoscope of 30 ° was inserted following induction of pneumoperitoneum (12 mm Hg) with a Veress needle, and a massive hemoperitoneum was visualized and aspired by suction irrigation device. Three additional trocars, left side to umbilical port for the surgeon, and third left side for the assistant were laid in the epigastrium .Careful abdominal cavity inspection con rmed the spleen was the sole source of bleeding (pic 2). The spleno-colic ligament was broken downwards . By harmonic scalpel, the shorts of the gastric vessels and the attachments in the lower polar were divided. The splenic artery was prepared and ligated then cut .it is assured that the pancreatic tail was not damaged (pic 3,4). The lateral attachments were divided that allowed splenic mobilizations. With a 3-cm incision and through endobag, the spleen was removed (pic 7).Extensive uncontrolled bleeding is an indication for laparotomy. (pic 5,6).
Postoperatively, Fluid was allowed as tolerated when the patients had open bowel. Antibiotics were continued for 5 days. A drain removed when contains less than 50 C.C for 3 days. Vaccination occurred after 2 weeks of postoperative surgery. The follow up period was one month, six month, twelve month and 18 months after returning home. After returning to home, patients were contacted by mailing, telephone and at outpatient clinic. Techniques of follow up included complete history and physical examination to detect remote complications and Ultrasonography if patients are symptomatizing at any time in the follow up period. No cases lost in the follow up period.

Statistical analysis
The data were imported into the Social Sciences Statistical Package (SPSS version 20.0). The following tests were used for testing of difference of signi cance, depending upon the type of data qualitative as number and percentage quantitative continuous group represented by average ± SD, and Chi square test differential and associate qualitative variable (X2). Differences between quantitative independent groups by t test or Mann Whitney, for signi cant results P value was set at < 0.05 & < 0.001 for high signi cant results.

Results
There was no signi cant difference or association between groups as regard age,sex and causes of splenic injury (p=0.374, 0.41, 0.38).Most cases were under 35 years old male patients exposed to motor car accidents..

Discussion
Laparoscopic approach for splenectomy in elective cases is the standard treatment but laparoscopic approach in traumatic high grade splenic injuries is not common. Changes in surgical approach evolved in the last decade secondary to the urging of technology.
Studies performed on grade III splenic injuries and stated that the operative time is longer in laparoscopic splenectomy than open approach while no difference in morbidity and mortality between both approaches and stated that laparoscopic splenectomy is a safe approach [14][15]. The present study agree with the previous studies, most cases were in grade III (47/70) with less intraoperative bleeding in laparoscopic group but with longer operative time (91% of cases).Longer laparoscopic time is attributed to time taken for introduction of trocars and laparoscopic instruments. Minimal intraoperative bleeding was due to panoramic view that helped us in controlling the bleeding site and thanks to the presence of Harmonic scalpel instrument. New technologies provided a special excellent instrument as harmonic scalpel and ligasure that are excellent tool in hemostasis during the surgery and the operation must be performed after availability of these tools [16]. In the present study, the harmonic scalpel allowed us to quickly dissect the short gastric vessels, especially the ligamentous attachments of the lower poles of the spleen and hence decrease operative time and bleeding.
Conversion to open occurred in 5 cases (14%) due to failure to control bleeding during the operation. three cases converted at the rst few minutes of operation due to inability to control bleeding and the last two cases are converted during dissection of the hilum of the spleen.
Panoramic view of the abdomen by laparoscopy helps to detect associated injuries and avoid missed injuries that may reach up to 18% of cases [17]. In our study; the missed injuries were high in open than laparoscopic group (14% vs. 3%) and mostly due to missed injury of pancreatic tail. Cases presented with intra-abdominal abscess and pain with fever. 4 cases of missed injuries in open group and one missed case in laparoscopic group were due to missed pancreatic tail injuries. All of them were grade B stula and were treated successfully by percutaneous drainage under ultrasonography guidance, nothing per oris, metronidazole 500mg injection and third generation cephalosporin. No cases needed re-exploration. While the fth missed case of open group was due to colonic injuries and diagnosed 5 days postoperative by abdominal pain and fever and underwent re-exploration and temporarily simple loop colostomy that was closed 8 weeks after.
Among advantages of laparoscopy over open approach are small operative wound and hence pain and infection. Rapid resumption of oral feeding and rapid return to works are also advantages. [18]. the present study con rmed the importance of laparoscopy in less postoperative pain, less duration of analgesic intake and shorter hospital stay in laparoscopic approach than open approach.
Postoperative wound infection is related to the size of the wound, so larger wound in open approach is more liable to wound infection than in laparoscopic approach .In the present study, 15 cases (43%) in open approach and 2 cases (6%) with laparoscopic approach were complicated with wound infection. All cases treated according to culture and sensitivity with local wound drainage and antibiotic injection.
Overwhelming post-splenectomy (OPSI) infection is a serious condition following splenectomy and its incidence may be up to 2%. Infection occurred by capsulated bacteria and it is usually fatal in 70 % of cases complained of this problem [19]. Post-splenectomy vaccinations against the causative agents are available and are giver after 2 weeks of operation. [20] In the present study, no cases developed OPSI as all cases received polyvalent vaccines within 2 weeks after splenectomy and every 5 years till 25 years old.
Adhesive intestinal obstruction occurred in 8 cases in open approach and no one in laparoscopic approach. 6 cases responded to conservative treatment in the form of nothing per mouth nasogastric tube and adequate hydration. 2 cases not responding to conservative treatment with signs of strangulation that required re-exploration with resection and anastomosis of small bowel. one cases showed good outcome while the other developed fecal stula 10 days postoperative and died of sepsis.

Conclusions
In hemodynamically stable patients with high-grade splenic injuries, laparoscopic splenectomy may be performed safely in the presence of experienced surgeons and anesthesiologists. Surgery is easy by using modern ligasure apparatus that decrease intraoperative blood loss and hence blood transfusion but it added more cost to the surgery in our study.  the 2nd case converted to open approach due to uncontrolled bleeding from the hilum.